Osimertinib

Drug Profile

Osimertinib

Alternative Names: AZD-9291; Mereletinib; TAGRISSO

Latest Information Update: 12 Jan 2017

Price : $50

At a glance

  • Originator AstraZeneca
  • Developer AstraZeneca; Incyte Corporation; Kyushu University; National Cancer Institute (USA)
  • Class Acrylamides; Aniline compounds; Antineoplastics; Dimethylamines; Indoles; Pyrimidines; Small molecules
  • Mechanism of Action Epidermal growth factor receptor antagonists; Protein tyrosine kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Non-small cell lung cancer
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer
  • Phase II Carcinomatous meningitis
  • Phase I Solid tumours

Most Recent Events

  • 15 Dec 2016 AstraZeneca plans the phase III ADELOS trial for Non-small cell lung cancer (Monotherapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in China (PO, Tablet) (NCT02997501)
  • 13 Dec 2016 AstraZeneca plans to file a regulatory application for osimertinib for the treatment of Carcinomatous meningitis in USA, China, Japan and European Union (AstraZeneca pipeline, December 2016)
  • 12 Dec 2016 AstraZeneca plans to file a regulatory application for osimertinib as a first-line therapy in Non-small cell lung cancer in USA, China, Japan, European Union in 2017 (AstraZeneca pipeline; December 2016)
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